The Recall Desk

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.

37 recalls in our database name Fujifilm Medical Systems U.S.A., Inc. as the manufacturing or recalling firm.

What the numbers show

Total
37
Critical
0
Severe
0
Most recent
2021-06-09

Of the 37 recalls from Fujifilm Medical Systems U.S.A., Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 37

  • HighFDA (Devices)·Z-1775-2021·2021-06-09

    Synapse Cardiovascular software may incorrectly reuse patient database identifiers

    Fujifilm's Synapse Cardiovascular software versions 6.0.4 to 6.2.1 contain a defect in the Advanced Reporting function where previously assigned patient database identification numbers can be reused for new patients when specific patient merge operations are executed.

    Product
    Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2021·2021-04-14

    Fujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display

    Fujifilm Medical Systems is recalling Synapse PACS software because it may display incorrect patient information in the viewer or PowerJacket.

    Product
    Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0918-2021·2021-02-03

    Fujifilm Synapse PACS Software Recalled for Clinical Reporting Errors

    Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.

    Product
    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2021·2021-02-03

    Fujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error

    Fujifilm is recalling Wako HDL-C/LDL-C Calibrator Lot EL629 because incorrect concentration values were printed on the bottle labels, which may result in incorrect testing results.

    Product
    Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0282-2021·2020-10-28

    Fujifilm Synapse PACS Software Version 5.6.1 Recalled for CT Measurement Error

    Fujifilm is recalling Synapse PACS Software Version 5.6.1 because certain CT studies may report inaccurate 3D Sphere MAX values.

    Product
    Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2020·2020-07-08

    Fujifilm Synapse PACS Software Recalled for Incorrect Orientation Markers

    Fujifilm is recalling Synapse PACS Software versions 5.5.x and 5.7.x because incorrect orientation markers and slice locations may lead to misdiagnosis.

    Product
    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2019·2019-09-11

    Fujifilm FDR Go Plus X-ray System Recalled for Software Glitch

    Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.

    Product
    Fujifilm FDR Go Plus mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2019·2019-03-27

    Fujifilm FDR Go PLUS Mobile X-Ray System Recalled for Braking Defect

    Fujifilm is recalling 56 mobile X-ray systems because the braking mechanism may fail to engage when the handle is released.

    Product
    Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2018·2018-02-28

    Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error

    Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.

    Product
    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0661-2018·2018-02-28

    Fujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors

    Fujifilm is recalling ASPIRE Cristalle mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images in hospital systems.

    Product
    ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is in
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0660-2018·2018-02-28

    Fujifilm Recalls Digital Mammography Systems Due to Image ID Error

    Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0659-2018·2018-02-28

    Fujifilm Aspire HD Mammography System Recalled for Image ID Error

    Fujifilm is recalling Aspire HD mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    Product
    Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0386-2018·2018-01-24

    Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.

    Product
    ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for scree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0385-2018·2018-01-24

    Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect

    Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.

    Product
    Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digita
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0232-2018·2017-12-20

    Fujifilm FDR Visionary Suite X-ray Tube Recall for Cracking Risk

    Fujifilm is recalling three FDR Visionary Suite systems because cracks may develop in the X-ray tube holding shaft, posing a potential safety issue.

    Product
    FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts o
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3225-2017·2017-10-04

    Fujifilm Recalls 362 Fujinon ED-530XT Endoscopes for Reprocessing Risk

    Fujifilm Medical Systems is recalling 362 Fujinon ED-530XT endoscopes nationwide to reduce patient risk from inadequate reprocessing.

    Product
    FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3129-2017·2017-09-20

    Fujifilm Endoscope Corrective Action Following FDA Inspection

    Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.

    Product
    Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3128-2017·2017-09-20

    Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection

    Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.

    Product
    Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other pur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2706-2017·2017-07-19

    Fujifilm Recalls Ultrasonic Endoscope Model EG-530UT

    Fujifilm Medical Systems is recalling four units of the EG-530UT ultrasonic endoscope following a retrospective review.

    Product
    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0073-2017·2016-10-19

    Fujifilm Synapse PACS Software Recalled for Potential Image Data Errors

    Fujifilm Medical Systems is recalling Synapse PACS software versions 4.0 through 4.3 because patient image data may be incorrect.

    Product
    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2016·2016-09-07

    Fujifilm Digital Mammography System Recalled for Biopsy Workflow Error

    Fujifilm is recalling two Aspire HD Digital Mammography Systems because an aborted stereo biopsy may cause an error that prevents the system from operating properly.

    Product
    FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2043-2016·2016-06-29

    Fujifilm Synapse PACS Software Recall for Image Display Failure

    Fujifilm Medical Systems is recalling 27 units of Synapse PACS software versions 4.4.000 through 4.4.020 because the software fails to display medical images, showing an error message instead.

    Product
    Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation So
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1863-2016·2016-06-08

    Fujifilm ED-450XT5 Endoscope Manual Correction for Infection Risk

    Fujifilm Medical Systems is correcting the ED-450XT5 endoscope manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide